Analytical method validation for metformin quantification in dissolution medium
DOI:
https://doi.org/10.30574/gscbps.2019.7.2.0049Keywords:
Biological and Pharmaceutical Sciences, Validation, Analytical method, Quantification, Dissolution, SpectrophotometryAbstract
Metformin hydrochloride is a hypoglycemic agent used for type II Diabetes Mellitus treatment, and one of the most used to manage it. The objective of the present work was the development and validation of an analytical method to quantify metformin hydrochloride in the dissolution medium by UV spectrophotometry. Linearity and range, accuracy and precision were the validation process parameters. Validation process results showed the analytical method was easy, quick, secure and, furthermore, a linear, accurate and precise method in the studied concentrations range. Therefore, it is a reliable analytical method.
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References
Gong L, Goswami S, Giacomini K, Altman R and Klein T. (2012). Metformin pathways: pharmacokinetics and pharmacodynamics. Pharmacogenetics and Genomics, 2-13.
United States Pharmacopoeia 40 (USP). (2017). United States Pharmacopoeia 40 (40 ed.). Rockville: U.S. Pharmacopoeial Convention.
Wegscheider, W. (1996). Validation of Analytical Methods. In: H. Günzler, Accreditation and Quality Assurance in Analytical Chemistry, Berlin, 134-158
COMIECO. (2006). Reglamento Técnico Centroamericano: Productos Farmacéuticos. Validación de Métodos Analíticos para la Evaluación de la Calidad de los Medicamentos. From http://asp.salud.gob.sv/regulacion/pdf/rtca/rtca_11_03_3906_productos_farmaceuticos_metodos_analiticos.pdf
Ministerio de Salud de Costa Rica. (s.f.). Guía de Validación de Métodos Analíticos. San José. From http://www.netsalud.sa.cr/ms/drc/pciudadano/guia_01.doc
Food and Drugs Administration (FDA). (1996). Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology. Rockville. From https://www.fda.gov/downloads/drugs/guidances/ucm073384.pdf
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